Turing Pharmaceuticals founder Martin Shkreli caused a stir when he jacked up the cost of an old drug used by AIDS patient from $13.50 to $750 earlier this year after his company acquired the rights to it.
Now, the 32-year-old is yet in another controversy after he suggested that his new company, KaloBios Pharmaceuticals Inc., would also raise the price of a lifesaving drug for the potentially fatal parasitic infection Chagas disease.
Chagas is caused by the parasite Trypanosoma cruzi found in the feces of the kissing bug. The condition may cause difficulty in defecating and swallowing and may lead to serious heart problems years later.
Shkreli's investor group acquired 70 percent of the shares of the KaloBios last month with a reported investment of at least $3 million. This allowed Shkreli to apply for the so called priority-review voucher from the U.S. Food and Drug Administration (FDA), which could speed up the approval of the drug benznidazole's sale in the U.S.
Chagas disease, which affects about 300,000 individuals in the U.S., is considered as one of the neglected parasitic infections so the drug is eligible for a priority review voucher.
Benznidazole is currently only available in the U.S from the Centers for Disease Control and Prevention (CDC), which offers it to patients for free via an experimental program albeit the drug is already available in other parts of the world. In Latin America, it is priced as little as $50 to $100 per two-month treatment course.
Shkreli announced in a public conference call with investors last week that no clinical trials will be needed for the marketing application of the drug and the toxicology and pharmacokinetics study results will allow the company to file for approval next year.
He also said that he would give the drug price similar to those of hepatitis C drugs, which can cost patients up to $80,000 for a full treatment.
The announcement has provoked alarm in the medical community with some critics saying that this is a case of the system being taken advantage of by awarding a voucher not for developing a new drug but for just getting the health regulator's approval for a drug that is already used in tropical countries.
"It's caused a lot of angst in the Chagas community," said Sheba Meymandi, from the University of California, Los Angeles. "Everyone's in an uproar."
